Aviceda Therapeutics’ eye disease drug will advance to Phase III, despite it failing to meet the primary endpoint in a Phase IIb trial.
In the SIGLEC study (NCT05839041), AVD-104 showed no statistical difference compared to Astellas Pharma’s Izervay (avacincaptad pegol), a standard of care (SoC) treatment, in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Aviceda said that imbalances in key baseline lesion characteristics across treatment arms contributed to the lesion-growth outcomes.
There was some benefit seen in secondary endpoints, with the trial reporting a clinically meaningful reduction of 31% in GA lesion-growth rates in AVD-104-treated patients versus sham and natural history data.
Sustained improvement in mean best-corrected visual acuity (BCVA) saw an increase of ≥5, ≥10, and ≥ 15 letters in 28.9%, 16.9% and 4.8% of patients, respectively.
The candidate also touted a favourable safety profile with 2% of patients developing neovascular AMD.
Aviceda Therapeutics's chief medical officer Dr David Callanan said: “We are encouraged by the magnitude of visual acuity gains, including protection from significant vision loss, reduction in lesion growth relative to historical sham and expected natural history, and the compelling safety profile observed with monthly AVD-104.
"We believe AVD-104 is poised to address critical gaps in current GA therapies that limit adoption, such as the lack of functional vision benefit and the safety limitations of neovascular AMD conversion.”
Based on promising signs from the Phase II trial, the company will advance AVD-104 into two randomised, sham-controlled Phase III confirmatory studies, with trial initiation expected in 2026.
Further data from the Phase IIb SIGLEC trial will be presented at medical congresses in 2026.
AVD-104 is also being investigated in uveitis and retinal degeneration. The company was also running a Phase II trial of the candidate in diabetic macular oedema; however, the study was terminated due to insufficient study drug supply and study funding constraints, according to the ClnicalTrials.gov listing.
GA SoC seen significant shift
As well as Izervay, which gained US Food and Drug Administration (FDA) approval in August 2023, Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) is also considered SoC in GA. Syfovre was awarded approval by the FDA in February 2023.
The drugs’ approvals marked a significant change in SoC from supportive management, monitoring, and AREDS2 supplements to disease-modifying therapies (DMTs).
GlobalData predicts sales of Iservay to reach $1.55bn in 2031, while Syfovre sales are set to reach $1.13bn in the same year.
GlobalData is the parent company of Clinical Trials Arena.
Other companies investigating drugs for GA include Boehringer Ingelheim, which has initiated a Phase II trial of its oral treatment BI 1584862. Alkeus Pharmaceuticals has also been investigating its oral candidate gildeuretinol in a Phase III trial in GA, which has shown the drug to be successful in reducing the growth rate of lesions, but this change was only “clinically meaningful”.
According to GlobalData analysis, the global AMD market as a whole is due to reach sales of $27.5bn in 2031, with the US anticipated to account for 72.1% of this.
